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Calimmune: Safety Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-

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buginme2:

--- Quote from: JazJon on May 03, 2013, 03:32:34 AM ---I just had an interesting discovery.    Anyone that volunteers for a clinical trial that has you STOP your ART (such as Calimmune) might actually be doing TWO experiments.  Check this out.

Topic: Early HIV drugs 'functionally cure about one in 10'
http://forums.poz.com/index.php?topic=47816.0

Here's where I possibly come in:

Here's a copy and paste:
_______________________________________________

http://forums.poz.com/index.php?topic=47816.msg587206#msg587206

Maybe I'll end up as a post controller?   I actually have a potential situation where I'll be able to find out in several months.  (I'll post my results if/when it happens)

Details.........
I was diagnosed early 2012.   I had a pretty bad flu for 3 weeks so I got tested.  They told me I had a VL of 2 million, but still tested negative for antibodies.  (they have a dual HIV test at the clinic I went to)  So that means I caught it about as early as it gets.

I did research and I jumped into a clinical trial of a new CC5 blocking med:
http://www.aidsmeds.com/archive/cenicriviroc_2656.shtml  (with Truvada)
(when I started, I felt normal, and VL was pretty low naturally)
I became undetectable in several weeks. (and zero side effects)

I just completed the cenicriviroc trial and switched to complera a month ago. (again zero side effects)

The next trial I'm on the top of the list to participate in Arm 2 or 3 of the Calimmune Gene transfer trial.
http://forums.poz.com/index.php?topic=46455.0

Here's the interesting part.........

I need to STOP taking my meds several weeks before I get treated via Calimmune.    I never imagined that I might remain undetectable after I stop ART.  I'll have been on ART nearly 2 years by the time they would want me.   The fact I was on the CCR5 blocking cenicriviroc for so long and started so early gives me a decent chance at least.   I was told I was the healthiest patient in every program they have across the board too.   So pending my qualification for Calimmune, and they call me,  I'll consider it a double experiment!

I'm pretty sure I was told the Calimmune trial requires you to actually have a detectable VL before they'll treat you.    What if I remain UD month after month?  I would imagine they want test groups to be detectable so they can rule out the potential Post-treatment controller anomalies

________________________________________________

--- End quote ---

Regarding methotrexate, the NIH states methotrexate may cause serious side effects including death.  You should only take methotrexate to treat life threatening cancer or certain other conditions that cannot be treated with other medications.

Bulsulfan, while not as dire as methotrexate can cause a severe decrease in blood cells in your bone marrow and has been shown to increase the risk that you will develop other cancers.  It is considered a class 1 carcinogen.

buginme2:
It's highly doubtful the fda would allow a study to use methotrexate to treat hiv.  Kenya must not have as strict a regulatory system to protect patients.

POZnLA:

--- Quote from: JazJon on May 03, 2013, 03:32:34 AM ---I just had an interesting discovery.    Anyone that volunteers for a clinical trial that has you STOP your ART (such as Calimmune) might actually be doing TWO experiments.  .......  .................  ..............  .................................................  .................  ........................
I need to STOP taking my meds several weeks before I get treated via Calimmune.    I never imagined that I might remain undetectable after I stop ART.  I'll have been on ART nearly 2 years by the time they would want me.   The fact I was on the CCR5 blocking cenicriviroc for so long and started so early gives me a decent chance at least.   I was told I was the healthiest patient in every program they have across the board too.   So pending my qualification for Calimmune, and they call me,  I'll consider it a double experiment!

I'm pretty sure I was told the Calimmune trial requires you to actually have a detectable VL before they'll treat you.    What if I remain UD month after month?  I would imagine they want test groups to be detectable so they can rule out the potential Post-treatment controller anomalies


--- End quote ---

The Calimmune study does not have you stop your ART, what they do is look for persons that have already stopped at least 6 weeks prior to thier 1st screening.

copy and paste from the study posting of inclusion requirements
__________________________________________________________

* Not taking antiretroviral therapy for ≥ 6 weeks prior to Screening 1, for one or more of the following reasons:

i) Concerns over short-term or long-term toxicities associated with antiretroviral agents, or ii) Treatment fatigue from the daily regimen of life-long therapy
____________________________________________________________

Now if you wanted to be in the study, you may first stop because you have these concerns. I stopped my ART meds at the recommendation of my Dr. because of severe allergic reactions to my meds,  I am scheduled for screening and study procedures this summer.

JazJon:
I almost forgot about that important part.  It's true, they can't ethically ask you to stop taking your meds.    It's assumed you will and want to stop taking meds for "other" reasons before hand.    (such as the one you listed)

"i) Concerns over short-term or long-term toxicities associated with antiretroviral agents, or ii) Treatment fatigue from the daily regimen of life-long therapy"
((works for me))

SFGMOMO:

--- Quote from: JazJon on May 01, 2013, 10:13:39 PM ---I hope the Group 1 data is shared right away, or a Group 1 person chimes in on here. (or if anyone else hears an update they can share)

--- End quote ---

I very much appreciate the info being shared here -- the folks at Quest tell me I'm the first participant in Group 1 in San Francisco, so hopefully I'll have something worthwhile to contribute soon.  So far I've completed all the screenings, and the first apheresis was this week.  I agree it's an exciting study, and am looking forward to learning about the results.

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